Sr Computer System Validation (CSV) Engineer

JOB POSTING 

 

About Forge  

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

 Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.   

 

About The Role  

We are currently seeking a Sr Computer Systems Validation (CSV) Engineer to join the Forge Biologics team, a member of Ajinomoto Bio-Pharma Services.  The CSV Engineer will be responsible for determining system criticality, defining validation requirements, developing systems validation documentation, generating, and executing test protocols, and summarizing validation activities in reports. This individual will play a key role throughout the software development life cycle (SDLC) for the validation of new systems and changes for existing systems, to assure that all critical systems remain in a validated state. Their focus will be on computerized systems in support of Forges applications and GMP equipment. Forge provides and maintains a state-of-the-art multi-purpose gene therapy facility for pre-clinical and commercial product manufacturing and testing.

 

What You’ll Do  

•  
  • Authorship, execution, review, and approval of computer system validation deliverables throughout the software development lifecycle (SDLC), developed in partnership with functional teams, ensuring the documentation meets regulatory requirements and quality standards.
  • Collaborate with project team members, including Technical Services, Operations, IT/Automation, Development, Quality, and others to define needs and achievable solutions and/or justifications to system requirements.  Translate system requirement specifications into executable validation plans and protocols.
  • Maintain validation status of GxP computer systems
  • Draft and execute validation deliverables such as
  • Intended Use (IU)
  • • Requirement Specification (URS and FRS)
    • Requirement Risk Assessments (RRA)
    • System Design and Configuration specifications
    • Validation Project Plan
    • User acceptance testing (UAT)/Performance Qualification (PQ)
    • Traceability Matrix (TM)
    • Validation Summary Report
    • Data Integrity/Part 11 testing
  • Support GMP Manufacturing and Laboratory Equipment Software Validation and System Integration efforts
  • Provide support in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state
  • Support to quality investigations, continuous improvements, and change controls by providing technical and validation assessments
  • Support internal and external audits as CSV Subject Matter Expert (SME)
  • Lead continuous improvement of CSV procedures and processes
  • Demonstrate technical expertise to define approaches and execution of computer system validation activities in accordance with cGMP, GAMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q9, Annex 11 and applicable regulations, good engineering practice and industry standard procedures.

What You’ll Bring  

• Bachelor’s Degree in Engineering or related discipline
• Experience working in the Biotechnology, Pharmaceutical, Medical Device or other regulated industry. 
• Experience with Supervisory Control and Data Acquisition (SCADA) Systems and GMP Network integration (Active Directory, data transfer, etc.) of GMP Equipment
• Working knowledge of current good manufacturing practice (cGMP) CFR Parts 210 and 211
• Working knowledge of International Society for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 21 CFR Part 11 and Annex 11 regulations
• Must have strong attention to detail, be organized and proactive.
• Strong verbal and written communication skills.